FDA Recall D-0113-2018
Advanced Pharma Inc. · Houston, TX
Class I — life-threatening Terminated 663 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
Reason for recall
Subpotent Drug: found to be below the specification for labeled assay.
Recall record
- Recall number
D-0113-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA to hospitals and medical facilities.
- Recall initiated
- 2017-06-09
- Classified by FDA Center
- 2017-12-20
- FDA published
- 2017-12-27
- Terminated
- 2019-04-03
- Recalling firm
- Advanced Pharma Inc.
- Firm location
- Houston, TX